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- The judgment that a research activity involves “minimal risk” depends on a comparative assessment that the potential for negative efects to the human subjects of the research must be judged to be no more than the potential for negative efects ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
www.nsf.gov/pubs/2008/nsf08203/nsf08203_5.pdf
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What is the final rule for minimal risk studies?
What is a minimal risk study?
What is “minimal risk”?
How does the final rule affect research studies at Princeton?
When is the effective date of the Final Rule?
What is HHS' final rule?
Oct 8, 2024 · Under the Final Rule, a study is presumed to be minimal risk if it meets one of the categories of the HHS Secretary's list. If the expedited reviewer determines that the study involves more than minimal risk, what can the reviewer do? A. Determine the research is exempt from the regulation B.
The Final Rule updated continuing review requirements to: No longer require continuing review for research initially approved using expedited review procedures. Under the Final Rule, a study is presumed to be minimal risk if it meets one of the categories of the HHS Secretary's list.
Most minimal risk studies subject to the 2018 Common Rule requirements. Which Adverse Events must be reported promptly to the IRB? AEs that are unexpected, related or possibly related, and suggest greater risk of harm than was previously known.
Final Rule uses the term “individuals with impaired decision-making ability” to replace the term “mentally disabled persons.” The Final Rule’s preamble states that the possibility of coercion or undue influence could affect the ability to make an informed decision about participating in research.
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§ Minimal Risk • Concept of minimal risk is key to numerous Common Rule provisions. • Affects the type of review required, the frequency of review, considerations for IRBs in the review process, and the permissibility of waiver of informed consent. § IRB § IRB Approval Unchanged Definitions
the final rule added the requirement that Key information essential to decision making receive priority by appearing at the beginning of the consent document and being presented first in the consent discussion.
The Final Rule eliminates the process of annual IRB review called “continuing review” for minimal risk studies. This change affects most research studies at Princeton. Consequently, to manage these records, the IRB will grant three year approval periods for minimal risk studies.
